ICCVAM Contributions to OECD Activities

ICCVAM member agencies participate in the development and national review of chemical testing guidelines issued by the Test Guidelines Programme of the Organisation for Economic Co-operation and Development (OECD). OECD guidelines are used by government, industry, and independent laboratories of the 38 OECD member countries to assess chemical safety. ICCVAM members also serve on OECD expert groups for topic areas such as skin sensitization, eye irritation, and quantitative structure-activity relationship modeling.

The U.S. National Coordinators for the OECD Test Guidelines Programme, who are members of ICCVAM, solicit and collate U.S. comments on draft test guidelines and other documents of the Test Guidelines Programme. The National Coordinators represent the United States at the Working Party of National Coordinators annual meeting and in other test guideline development activities.

In a January 2023 statement, the Working Party of National Coordinators called for “urgent mobilisation of national and regional resources for the demonstration of reproducibility and reliability of methods developed in single laboratories.” In a statement, the National Coordinators noted a lack of funding for studies to demonstrate transferability and reproducibility of a new chemical safety testing method outside the developer’s laboratory. Lack of funding for such validation studies is hindering progress toward implementation of new methods with the potential to reduce use of laboratory animals and better protect human health and the environment. Read the full statement.

Ongoing Activities and Documents Under Review

ICCVAM members and/or NICEATM staff are supporting the Test Guidelines Programme by:

Supporting OECD activities to revise Test Guidelines Programme resources and processes to better support uptake of emerging technologies. Workshops held in December 2022 and December 2023 focused on how to prepare for emerging technologies and practical and financial aspects of validation studies, respectively. ICCVAM members assisted in organizing these meetings and provided expert participants.
Co-leading a project and participating in an OECD expert group coordinating revision of Guidance Document 34 on validation and acceptance of new or updated test methods for hazard assessment.
Leading development of the OECD Omics Reporting Framework. This modular framework released in 2023 facilitates data sharing for toxicology experiments using various types omics approaches (i.e. transcriptomics, metabolomics), increases transparency of omics data processing and analysis approaches, enables quality assessments, promotes reproducibility in omics experiments, and fosters the uptake of omics data for use in regulatory processes (Harrill et al. 2021).
Serving on an expert group considering test batteries for developmental neurotoxicity (DNT). NIEHS and EPA scientists developed a case study on application of integrated approaches for testing and assessment for DNT, which was published by OECD in 2022. Expert group members also contributed to a 2023 guidance document on evaluating data from in vitro DNT test batteries.
Further developing guidelines for skin sensitization defined approaches. "Guideline No. 497: Defined approaches on skin sensitization" was adopted in June 2021 and revised in July 2023. It describes defined approaches with respect to their intended regulatory purposes of hazard identification or potency subcategorization. NICEATM and ICCVAM scientists are currently contributing to two proposals to update Guideline 497 to include new information sources for existing DAs, and new DAs for quantitative risk assessment.
The proposal to develop the guideline for defined approaches was a product of a 2016 skin sensitization workshop convened by the International Cooperation on Alternative Test Methods.
Participating in expert groups evaluating methods to assess thyroid disruption and considering emerging science in chemicals assessment.
Participating in a group developing a "Case Study on the Use of an Integrated Approach to Testing and Assessment for Identifying Androgen Receptor Active Chemicals," submitted to the OECD Working Party on Hazard Assessment in 2019.
Participating in annual meetings of the OECD Validation Management Group-Non-animal, which focuses on evaluation of new methods for identifying endocrine disruptors.

Recent Activities

ICCVAM scientists contributed to two proposals to update OECD Guideline 497 for defined approaches to skin sensitization to include new information sources and a new data interpretation procedure for defined approaches. A new project to revise Test Guideline 497 was accepted by OECD in April 2022.
ICCVAM scientists contributed to a proposal to update OECD Test Guideline 496 for in vitro test methods to identify eye irritants to add the OptiSafe test method to the guideline. An updated to Test Guideline 496 was accepted by OECD in 2024.
NICEATM scientists have participated in expert meetings on skin sensitization and skin and eye irritation in since 2016.
NICEATM scientists participated on a peer review panel for an OECD-coordinated study to evaluate the use of the kinetic direct peptide reactivity assay for classifying substances for skin sensitization potency.
ICCVAM members contributed to a retrospective review of available data and information to support an OECD test guideline for a human reconstructed epidermis model for phototoxicity testing. "Test No. 498: In vitro phototoxicity - reconstructed human epidermis phototoxicity test method" was adopted in June 2021.
NICEATM and ICCVAM scientists participated in a group developing a "Case Study on the Use of an Integrated Approach to Testing and Assessment for Identifying Estrogen Receptor Active Chemicals," submitted to the OECD Working Party on Hazard Assessment. This case study was published in September 2019, and has since been adapted to create a proposal for a defined approach for estrogenic activity, submitted to the OECD in November 2019.